BBI Solutions welcomes consortium progress as COVID-19 antibody test reaches design freeze stage

BBI Solutions, part of the UK-Rapid Test Consortium (UK-RTC), has reached a ‘major milestone’ in the development of a COVID-19 lateral flow antibody test.

The UK-RTC has announced that it has reached design freeze for the test, which has been designed for people to use in their own homes.

The ‘major milestone’ means that the test meets the required performance characteristics and the producion specifications of the assay, or laboratory procedure, have now been set. The next stage will see the scale-up of processes this month, in readiness for manufacture.

Tests carried out prior to reaching the design freeze stage reported a 98.6% accuracy. The UK-RTC is continuing to work with the regulatory authorities to ensure approval of the test as quickly as possible.

As part of its role within the Consortium, Crumlin-based BBI Solutions continues its work to optimise its smartphone based reader technology for this application.

BBI’s patented technology will guide users at home through performing a test before securely sharing the results directly with the NHS.

The process will help ensure that people who have never performed a test like this before get the right result and feel confident in understanding it, while making sure that the NHS receives all the data from each test to help them plan and manage the disease’s progression.

Dr Mario Gualano, Chief Executive of BBI Group, said: “BBI have been at the forefront of using mobile technology to support point of care testing and the transformation that new technologies bring to this market.

“We are delighted to be part of the solution; from developing key components of the test to supporting manufacturing capacity and providing this pivotal mobile technology that will enable diagnostics to be delivered on a scale the UK has never seen before.”


For further information, contact Alastair Milburn, Effective Communication via [email protected] and 07813 857328


Notes to editor:

  • The “UK Rapid Test Consortium” (UK-RTC) comprises Oxford University, BBI Solutions, Abingdon Health, Omega Diagnostics and CIGA Healthcare.
  • The UK-RTC is utilising BBI Solutions’ rapid test development and expertise, as well as its wider manufacturing capabilities, primarily at its headquarters at Crumlin, South Wales, and its site in Edinburgh.
  • This latest milestone means that the test meets the required performance characteristics and the production specifications of the assay or investigative laboratory procedure, have now been established
  • BBI Solutions is also drawing on resource and expertise in other parts of the global BBI Group, in the United States, China and South Africa
  • More information about the Government announcement regarding the UK-RTC can be found here.


(Image; Dr Mario Gualano, Group CEO)

BBI Solutions has welcomed the ‘significant progress’ made by the UK-Rapid Test Consortium (UK-RTC) – of which it is a part – to develop a COVID-19 lateral flow antibody test.

Seven weeks ago, the UK Government commissioned the UK-RTC to develop a COVID-19 lateral flow antibody test that can be used by people in their homes.

The UK-RTC says it has made ‘significant progress’ in both developing the antibody test, as well as progress with the regulatory and logistics challenges needed to be able to deploy the test directly with individuals across the UK.

The Consortium has reported that it is now consistently picking up positive samples across the range, including weak positives, while ensuring negative samples are not detected.

It has conducted a small-scale study of 66 samples, and results suggest the test is performing in line with design requirements.

Later this month, the UK-RTC expects to reach design freeze – a binding decision among the consortium partners – which will allow it to move onto scale up, verification and validation activities, prior to the test being made available for manufacture.

In parallel with the above activities, the consortium is working with the UK Government and regulatory authorities to ensure proper approval of the test as quickly as possible.

The consortium is working with NHSX – the technology, digital and data service of the NHS – to develop a test specific app and digital service that will facilitate use and reading of the test device. This will have the ability to integrate with NHS systems and update records.

Given the scale of the potential demand for the test within the UK, critical planning around supply chain logistics is also well under way, which will ensure a smooth introduction of the test directly to the public.

Crumlin-based BBI Solutions is playing a key role as a consortium partner in the UK-RTC work, specifically in terms of leading on the development of the app, and providing critical reagents for the test.

BBI Group chief executive Dr Mario Gualano said: “This is a very complex project that is being completed at extraordinary speed, compared to a normal test development programme.

“But we remain on track to deliver a test to the UK that will make a significant difference to the approach needed to manage COVID-19 infections.

“We are proud to be an integral part of this project, and are delighted with the progress to date.”

For further information, contact Alastair Milburn, Effective Communication via [email protected] and 07813 857328

Notes to editor:

· The “UK Rapid Test Consortium” (UK-RTC) comprises Oxford University, BBI Solutions, Abingdon Health,  CIGA Healthcare and Omega Diagnostics.

· The UK-RTC is utilising BBI Solutions’ rapid test development and expertise, as well as its wider manufacturing capabilities, primarily at its headquarters at Crumlin, South Wales, and its site in Edinburgh.

· BBI Solutions is also drawing on resource and expertise in other parts of the global BBI Group, in the United States, China and South Africa.

· More information about the Government announcement regarding the UK-RTC can be found here.

Left; Damian Evans, Global Head of Quality. Right; Dr Mario Gualano, Group CEO

BBI Group completes Acquisition of DIARECT AG

(Image. Left; Damian Evans, Global Head of Quality. Right; Dr. Mario Gualano, Group CEO)

BBI Group, the world’s leading independent provider of immuno-diagnostic reagents and contract services, has today announced the acquisition of DIARECT, a leading supplier of autoimmune antigen products.

The acquisition of DIARECT and their world leading recombinant autoimmune antigen capability immediately enhances BBI’s portfolio and position as a ‘complete’ immunoassay reagent supplier and therefore a natural partner for our customers

This further enhances BBI’s position as the world’s largest diagnostics components company with a market leading antigen portfolio.

The UK-based business, which has manufacturing sites and sales offices across four continents, will integrate DIARECT’s state of the art manufacturing facility in Germany, to establish a Centre of Excellence for recombinant antigen development & manufacturing in Freiburg.

DIARECT has seen significant growth for its innovative product lines which are used in a wide variety of tests to assist in the diagnosis of various autoimmune and infectious diseases.

BBI Group Chief Executive Officer, Mario Gualano said:

“The acquisition of DIARECT immediately enhances our portfolio and positions BBI as a ‘complete’ immunoassay reagent supplier and therefore a natural partner for our customers.”

The combined capability enables BBI to further service high growth disease segments such as cancer, cardiac conditions and diabetes, while also enabling BBI to drive geographic expansion for DIARECT, which will benefit from a bigger sales force.

Heinz Haubruck, CEO and co-founding shareholder of DIARECT said:

“The combined research and development capability will provide our customers with new, innovative products. This and the expansion of our product portfolio will offer our customers a more comprehensive range of products”

Notes to Editors

· BBI Solutions is a leading manufacturer of biological reagents and finished test platforms for the in-vitro diagnostics market. BBI is a global business with manufacturing sites and sales offices across four continents.

· BBI’s range of raw materials includes human antigens, antibodies, serum and plasma products and clinical chemistry enzymes. BBI manufactures world renowned labels for lateral flow, ELISA assay and biosensors, including gold nanoparticles and glucose oxidase.

· BBI Solutions offers lateral flow development and manufacturing services with a core focus on antibody development, gold conjugation, lateral flow test manufacture and mobile diagnostic solutions with Novarum™ technology.

· BBI Solutions is part of the BBI Group.

Media Contact

Alastair Milburn (Effective Communication)

T: +44 (0)7813857328

E: [email protected]

BBI Solutions responds to Government call-to-arms to roll out millions of coronavirus tests

Crumlin-based company part of consortium launched to develop new antibody tests

Government sets challenge to industry to help achieve 100,000 tests a day by end of April.

Crumin-based BBI Solutions has today (April 8) been announced as part of a consortium of the UK’s top Diagnostic companies to rapidly develop and rollout millions of coronavirus tests.

As part of the Government’s National Testing Plan, the expertise and resources of the UK’s world-leading life sciences industries are being pooled to build a large British diagnostics industry as quickly as possible.

The “UK Rapid Test Consortium, UK-RTC” comprises Oxford University, BBI Solutions, Abingdon Health, CIGA Healthcare, and has been launched to design and develop a new antibody test to determine whether people have developed immunity after contracting the virus.

All existing antibody tests that have gone through the validation process have not proven accurate enough, therefore the government is backing efforts to develop a home-grown test.

New national collaborations such as the UK-RTC will contribute to the Government’s wider target to carry out 100,000 tests a day by the end of April, focusing on frontline healthcare and other essential workers first before deploying the tests to the wider population.

The consortium will draw on BBI Solutions’ rapid test development and expertise, as well as its wider manufacturing capabilities, primarily at its headquarters at Crumlin, South Wales, and its site in Edinburgh.

The company will also draw on resource and expertise in other parts of the global BBI Group, in the United States, China and South Africa.

BBI Group CEO Dr Mario Gualano said: “BBI Solutions is honoured and privileged to be invited to be part of this consortium, and its critical work.”

“Utilising the resources and expertise across BBI Solutions’ global business, we are moving quickly and effectively to seek solutions that will enable the UK to rollout a significantly scaled-up coronavirus testing programme.”

More information about the Government announcement regarding the UK-RTC can be found here

For further information, contact Alastair Milburn, Effective Communication, [email protected] and 07813 857328.


Novarum granted European patent for smartphone diagnostic technology

Smartphone diagnostic specialist Novarum™ DX has achieved a significant milestone in the development of its revolutionary technology after being officially granted a European patent.

Novarum has been awarded the patent (EP 12718728.4) for its smartphone diagnostic technology by the European Patent Office (EPO), having already secured the equivalent patent for its technology in the United States earlier this year.

The patents protect Novarum’s image-capture technology which transforms a smartphone into a diagnostic reader when using the mobile’s camera to accurately scan the results of a rapid test.

Since the acquisition by BBI Solutions in 2016, Novarum has expanded its patent portfolio which now includes: China, Japan, Russia, the United States and Europe with a number of other territories pending.

Novarum Founder and BBI Group Head of Mobile, Dr Neil Polwart said: “The European patent bolsters Novarum’s position as a leader in smartphone-enabled point of care diagnostics”.

“As the second patent to have been awarded this year, we’re now able to protect our intellectual property across two key territories, the US and Europe.”

“Our technology corrects misalignments when reading diagnostic tests using the camera feature on a smartphone without additional hardware, ensuring that our solution is robust in delivering test results of lab quality.”

“Our patents safeguard our intellectual property and reaffirm Novarum’s position as pioneers for next generation diagnostic technologies.”

For more information about how Novarum is revolutionising point of care diagnostics, visit:

Economy Secretary opens BBI’s new global headquarters in Crumlin

Economy Secretary, Ken Skates has been in Crumlin to open the new £14m global headquarters of life sciences company, BBI Group.

Following a £1.8m package of Welsh Government support, the company has chosen the Caerphilly town as the location for its new global headquarters.

It has also centralised its manufacturing and development activities from sites in Blaenavon, Cardiff and Dundee onto one new state of the art facility site in Crumlin.

The move to Crumlin will see over 360 jobs being safeguarded and created in Wales by 2020.

This means that in line with the ambitions of the Welsh Government’s high level plan, Our Valleys, Our Future, BBI’s move will deliver high quality career opportunities in the South Wales Valleys and provide a significant boost to the local economy.

Economy Secretary, Ken Skates said: “As a highly successful company with a turnover of more than £60m and a strategically important player in the global life science sector, BBI Group is already a made-in-Wales success story.

“I am delighted that Welsh Government support has enabled the company to establish its global headquarters here and centralise its manufacturing and development activities in Crumlin, bringing new and high-quality job opportunities to the South Wales Valleys.

“This is absolutely in line with the ambitions of our high-level plan Our Valleys Our Future, and with the aspirations of my Economic Action Plan, which aims to ensure that the fruits of economic prosperity fall much more evenly across Wales.

“The Economic Action Plan is also clear about the economic growth opportunities of attracting global headquarters to Wales and our ambition to build on our success in this area.

“I am delighted to see BBI Group’s new state of the art facility in Crumlin first hand and wish the company every success in its new home.”

BBI Group Chairman Alan Peterson said: “The opening of our new Global Headquarters is a significant step towards realising our strategic long-term growth plans. It gives us the opportunity to compete more effectively in our key markets in Europe, USA and China.

“The Crumlin site enables BBI to drive our customers’ future growth by expanding our capacity to provide key reagents and services for the healthcare diagnostics industry. We’re delighted that our Global Headquarters is now open and we are able to contribute to the local economy and offer quality job opportunities to the local community.”

BBI Group appoints new CEO

The BBI Group has appointed a new CEO as it moves to its global headquarters in Crumlin, South Wales.

Mario Gualano, previously BBI’s Global Head of Commercial, took up the role of CEO following the departure of former CEO Lyn Rees.

Having completed his PhD in Microbiology and Immunodiagnostics at Cardiff University and his MBA at Henley, Mario brings over twenty years’ experience within the microbiology / diagnostics sector within Thermo-Fisher Scientific, most recently as President of the microbiology division.

Chairman Alan Peterson said: “I’m delighted that Mario Gualano will be taking up the helm as BBI moves to a world-class facility. Mario has a wealth of commercial, technical and operational experience which will be invaluable as BBI continues its growth journey.

“The Board would like to thank Lyn for his hard work, energy and enthusiasm over the past 17 years and wish him all the best in his future endeavours.”

Maine Biotechnology Services

BBI Group acquires Maine Biotechnology Services

The BBI Group, partner to the world’s leading diagnostic and healthcare organisations, has entered into a definitive agreement to acquire the Maine Biotechnology Services, Inc. (MBS) located in Portland, Maine (USA).

The acquisition of MBS will expand BBI’s portfolio during a period of expansion and growth. The company provides a range of products to the diagnostic, healthcare, research food sectors globally. MBS will add antibody development to its capability and product range.

The acquisition of MBS perfectly complements the company’s current product portfolio and coincides with its commercial team expansion, giving the company important new technology and products.

Dr Joseph Chandler, Founder and President of MBS, said: “The BBI Group was aware of our reputation in the market for high quality antibody products services. They currently have no capacity for antibody development and manufacture and, with a waiting customer base for this, MBS is a logical addition to their business. They are on an ambitious growth plan and I know that MBS will be a key part of their future plans.”

Cyber Essentials Plus

BBI awarded Cyber Essentials Plus certification

BBI Group is delighted to have been awarded Cyber Essentials Plus certification, the UK Government scheme that helps protect businesses from cyber-attacks.A copy of our certificate can be found here

BBI Group – Cyber Essentials Plus Certificate

The scheme has been designed to help protect UK businesses by preventing the most common forms of cyber-attacks and to make the UK a safer place to do business online.The Cyber Essentials Plus scheme provides a higher level of assurance, tested by a qualified and independent assessor who simulates hacking and phishing attacks.

BBI Group CEO Lyn Rees, said: “This achievement is a culmination of efforts over the last six months, involving many improvements to our IT processes and software security.

“The accreditation not only demonstrates the robustness of BBI’s IT infrastructure, but as Cyber Essentials is a mandatory requirement for government contracts this ensures our BBI Detection division can continue working with our MOD partners.”

To learn more about the Cyber Essentials scheme, visit their page on the UK Government website.

BBI Group Global Headquarters

BBI Group announce £14m investment to boost capacity and long-term growth

BBI Group today (February 7th, 2017) announced a new £14m investment plan for 2017 which will include a new global HQ and manufacturing centre of excellence for the company in South Wales.

The announcement takes the company’s overall investment to approximately £20m across 2016 and 2017.

The plans – supported by a £1.8m grant from the Welsh Government – will see BBI Group move to a new 120,000 sq ft headquarters at Crumlin, Caerphilly with excellent links to the M4 corridor and Cardiff International Airport.

The investment will aim, following consultation and internal business review, to consolidate BBI Group’s existing operations in Blaenavon, Cardiff and Dundee, providing improved manufacturing and enzyme production facilities to serve the global diagnostics and healthcare marketplace.

It will also give the company the pedigree to compete more effectively in the expanding markets in Europe, USA and China.

With Welsh Government and local authority backing, the investment also aims to create around 50 new positions up to 2020. This will provide excellent career opportunities in the South Wales Valleys region, foster closer links to the scientific and academic community, and provide a significant boost for the local economy.

Economy Cabinet Secretary Ken Skates welcomed the news today and said:

“BBI Group is a made-in-Wales success story; a highly successful company and a strategically important player in the life science sector globally.

“I am particularly pleased WG support helped secure this significant investment for Wales. Founded in 1986 as a Cardiff University spin out, BBI Group has grown to become a £60m turnover company and this expansion project will secure the company’s long term sustainable future in Wales.

“It will not only create and safeguard a significant number of high quality jobs but will also support the local economy through an annual spend of more than £1m with supply chain companies. In addition, the fit out and alterations of the building will support around 75 FTE jobs in the construction industry.”